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Not actual patient.
Fighting cancer is hard enough without worrying
about your child’s hearing loss, too.Thank goodness for PEDMARK
PEDMARK is a prescription medicine used to decrease the risk of hearing loss in children 1 month of age and older who are receiving cisplatin for solid tumors (cancer) that have not spread to other parts of the body.
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Just 1 cisplatin treatment cycle can lead to a lifetime of hearing loss
Currently, most children who receive platinum-based chemotherapy, such as cisplatin, develop hearing loss.
What is cisplatin-induced hearing loss?
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Not actual patient.
PEDMARK helps protect hearing in children receiving cisplatin-based cancer treatment
In clinical studies, PEDMARK significantly reduced the number of children who had hearing loss due to cisplatin-based cancer treatment when compared with those who did not receive PEDMARK.
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PEDMARK safety in children
A total of 232 children up to the age of 18 years received PEDMARK in the clinical studies.
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PEDMARK is the first and only FDA-approved sodium thiosulfate (STS) formulation for cisplatin-induced ototoxicity
No generic approved product exists or can be directly compared; PEDMARK is not substitutable with any other STS formulation.
- Evaluated in randomized clinical trials for its safety and efficacy in pediatric patients 1 month and older; the results are published in Lancet Oncology and The New England Journal of Medicine
- The only STS formulation shown in clinical trials to not interfere with the activity of platinum-based chemotherapy
- Supported by more than 10 years of study
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IMPORTANT SAFETY INFORMATION
- Do not allow your child to receive PEDMARK if they have had a severe allergic reaction to sodium thiosulfate or any of the other ingredients in PEDMARK.
- Allergic reactions can happen with PEDMARK and can be serious and life-threatening. Your healthcare provider will monitor your child for allergic reactions during the PEDMARK infusion. Your healthcare provider will stop the infusion and provide treatment if your child has an allergic reaction. If your child has an allergic reaction, your healthcare provider will give your child certain medicines before each PEDMARK infusion. Tell your healthcare provider right away if your child has any of these signs of an allergic reaction: rash, hives (raised bumps), chest tightness, wheezing, trouble breathing, swelling of the face, lips, tongue, or throat.
- Changes in salt and potassium levels in the blood are common with PEDMARK but can also be serious. Your healthcare provider will do blood tests to check your child’s sodium and potassium levels before starting and as needed during treatment with PEDMARK. Tell your healthcare provider right away if your child develops any of the following signs or symptoms: feeling tired or weak, feeling restless, muscle weakness, seizures.
- Nausea and vomiting are common with PEDMARK but can also be serious. Your healthcare provider will give your child medicines before each PEDMARK infusion to help prevent nausea and vomiting.
- The most common side effects of PEDMARK include decreased red blood cells (anemia).
- These are not all the possible side effects of PEDMARK. Call your child’s doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Fennec Pharmaceuticals, Inc. at 1-833-336-6321.
Please see full Prescribing Information, including Patient Information, for PEDMARK.
WHAT IS PEDMARK?
PEDMARK is a prescription medicine used to decrease the risk of hearing loss in children 1 month of age and older who are receiving cisplatin for solid tumors (cancer) that have not spread to other parts of the body.
It is not known if PEDMARK is safe and effective when given after cisplatin infusions longer than 6 hours.
It is not known if PEDMARK is safe and effective in children less than 1 month of age. PEDMARK is not recommended in children younger than 1 month of age.
